Gluten, Fecal, Quantitative

Casandra

Casandra Test Code LC29498Version 1 (DRAFT)

Performing Lab

Lab LabcorpLab Test ID 123027CPT Code 83520

Gluten, Fecal, Quantitative

Also known as: Fecal, Gluten, Gliadin 33mer, Stool, Gluten

Clinical Use

Order Test

Use

This Gluten ELISA test is intended for the quantitative determination of Gliadin 33mer in stool samples. This test may be used for the following applications:

Special Instructions

While the intestinal biopsy is the 'gold standard' for detecting mucosal damage, this non-invasive test offers a practical alternative for monitoring gluten ingestion. Persons using this test should ensure samples remain uncontaminated and handle collection carefully. Gluten in stool is detectable for up to four days post-consumption.

Limitations

This test was developed by Labcorp and has not been cleared or approved by the FDA. Serological markers like tTG IgA and EMA IgA have shown sensitivity below 50% for detecting villous atrophy in patients on a GFD. There is a significant need for more accurate monitoring methods for non-response to a GFD. While the test can indicate gluten exposure, it cannot account for all factors affecting gluten sensitivity.

Test Details

Methodology

Immunoassay (ELISA)

Biomarkers

LOINC Codes

Order Codes

100359-9

Result Codes

100359-9

Result Turnaround Time

4-6 days

Specimen

Stool

Volume

3 g

Minimum Volume

1 g

Container

Clean, screw-capped, plastic vial with no preservatives

Collection Instructions

Do not contaminate outside of container with specimen; do not overfill container. Loose/watery stools are acceptable. Ensure no toilet tissue/sanitary materials are present in the submitted specimen.

Storage Instructions

Refrigerate.

Causes for Rejection

Non-fecal sample received (e.g., serum, plasma, urine); stool contaminated with urine; samples from diaper unless uncontaminated; preserved stool received (e.g., 10% formalin, merthiolate formalin, sodium acetate formalin, or polyvinyl alcohol)